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EsoCheck + EsoGuard for Barrett's Esophagus Screening (ASBE Trial)
N/A
Recruiting
Led By Victoria T Lee, MD
Research Sponsored by Lucid Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
ASBE Trial Summary
This trial will compare healthcare provider decisions before & after being given EsoCheck/EsoGuard info; it'll measure how useful EsoCheck/EsoGuard is in helping docs decide if a patient needs endoscopy.
Who is the study for?
This trial is for board-certified physicians with 1-40 years of post-residency experience in fields like primary care, family medicine, gastroenterology, or foregut surgery. They must actively manage a large patient panel with over 50% adults.Check my eligibility
What is being tested?
The study tests the impact of EsoCheck/EsoGuard on doctors' decisions to refer patients for an upper endoscopy. It involves assessing patient cases before and after receiving educational material about these non-endoscopic screening tools.See study design
What are the potential side effects?
Since this trial focuses on physician decision-making rather than direct patient interventions, there are no side effects associated with EsoCheck/EsoGuard within the context of this study.
ASBE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral
Secondary outcome measures
The impact of EsoCheck/EsoGuard on health care provider's patient risk assessment for BE
ASBE Trial Design
6Treatment groups
Active Control
Group I: C2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm C1 with an EsoGuard result.
5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group II: A1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm A2 but without an EsoGuard result and in a different order.
Group III: A2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm A1 with an EsoGuard result.
5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group IV: B1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm B2 but without an EsoGuard result and in a different order.
Group V: B2 InterventionActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm B1 with an EsoGuard result.
5 EsoGuard negative cases (same cases for all intervention questionnaires) and 1 positive EsoGuard case (different for questionnaire A/B/C).
Group VI: C1 ControlActive Control1 Intervention
6 Virtual patient cases with GERD and similar BE risk factors as the cases in intervention arm C2 but without an EsoGuard result and in a different order.
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Who is running the clinical trial?
Lucid Diagnostics, Inc.Lead Sponsor
5 Previous Clinical Trials
1,627 Total Patients Enrolled
Medex15Industry Sponsor
2 Previous Clinical Trials
315 Total Patients Enrolled
Victoria T Lee, MDPrincipal InvestigatorLucid Diagnostics
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one year and no more than forty years of post-residency clinical experience in your field.You are a board-certified physician whose area of expertise encompasses preventive care, disease screening, diagnosis and management of esophageal diseases (such as primary care physicians/ general practitioners, family medicine physicians, gastroenterologists or foregut surgeons).You maintain a panel of at least 1000 patients, with adults comprising more than half.No specific criteria or restrictions apply.
Research Study Groups:
This trial has the following groups:- Group 1: C2 Intervention
- Group 2: A1 Control
- Group 3: A2 Intervention
- Group 4: B1 Control
- Group 5: B2 Intervention
- Group 6: C1 Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for participants in this experiment?
"Evidently, this research is not presently recruiting patients. This trial was initially posted to clinicaltrials.gov on April 9th 2023 and last edited on March 21st 2023. Luckily there are 42 other trials that are actively seeking volunteers at the moment."
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